Cognitive Impairment and Outcome of Acute Ischemic Stroke.

Ischemic Stroke Clinical Trial

Official title:

Correlation of Alberta Stroke Program Early CT Score (ASPECTS) With Cognitive Impairment and Outcome of Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235920
• Other study ID #: Mansoura University 12
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: June 2020
• Source: Mansoura University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to assess the use of ASPECTS and stroke biomarkers to predict the outcome and cognitive impairment in acute ischemic stroke.

Description:

150 patients (79 males, and 71 females with a mean age of 64.05±11.55 years) were included in this study presented by acute middle cerebral artery territory ischemic stroke. Vascular risk factors were determined from the history taking. Assessment of GCS and NIHSS at the initial presentation was done to assess the stroke severity. Cognitive functions were evaluated in all study participants by the Montreal Cognitive Assessment (MoCA) Arabic version. An initial and follow up non-contrast CT brain was done after 7 days which were assessed by ASPECTS. Functional outcomes in stroke cases were assessed after three months by Glasgow Coma Scale, National Institutes of Health Stroke Scale and modified Rankin Scale. Biomarkers of cognitive impairment like ESR, CRP, S100B, MMP9 and glutamate were evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• First attack of acute MCA territory infarction within 2 days from the onset.

Exclusion Criteria:

• previous stroke,

• presence of anterior cerebral artery infarction,

• posterior cerebral artery infarction, and

• venous infarction.

Related Conditions & MeSH terms

• Cerebral Infarction
• Cognitive Dysfunction
• Cognitive Impairment
• Ischemia
• Ischemic Stroke
• Outcome, Fatal
• Stroke

Intervention

Diagnostic Test:
• Montreal Cognitive Assessment (MoCA)
This scale evaluates different domains of cognition like attention, orientation, memory, language, visuoconstructional capacities, and lastly, executive functions. MoCA is a thirty point test with a score of 25 or less considered as abnormal impaired cognition

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Mokin M, Primiani CT, Siddiqui AH, Turk AS. ASPECTS (Alberta Stroke Program Early CT Score) Measurement Using Hounsfield Unit Values When Selecting Patients for Stroke Thrombectomy. Stroke. 2017 Jun;48(6):1574-1579. doi: 10.1161/STROKEAHA.117.016745. Epub 2017 May 9. — View Citation

Schröder J, Cheng B, Ebinger M, Köhrmann M, Wu O, Kang DW, Liebeskind DS, Tourdias T, Singer OC, Christensen S, Campbell B, Luby M, Warach S, Fiehler J, Fiebach JB, Gerloff C, Thomalla G; STIR and VISTA Imaging Investigators. Validity of acute stroke lesion volume estimation by diffusion-weighted imaging-Alberta Stroke Program Early Computed Tomographic Score depends on lesion location in 496 patients with middle cerebral artery stroke. Stroke. 2014 Dec;45(12):3583-8. doi: 10.1161/STROKEAHA.114.006694. Epub 2014 Oct 14. — View Citation

Tan JP, Li N, Gao J, Wang LN, Zhao YM, Yu BC, Du W, Zhang WJ, Cui LQ, Wang QS, Li JJ, Yang JS, Yu JM, Xia XN, Zhou PY. Optimal cutoff scores for dementia and mild cognitive impairment of the Montreal Cognitive Assessment among elderly and oldest-old Chinese population. J Alzheimers Dis. 2015;43(4):1403-12. doi: 10.3233/JAD-141278. — View Citation

Taylor-Rowan M, Wilson A, Dawson J, Quinn TJ. Functional Assessment for Acute Stroke Trials: Properties, Analysis, and Application. Front Neurol. 2018 Mar 26;9:191. doi: 10.3389/fneur.2018.00191. eCollection 2018. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal Cognitive Assessment	This scale evaluates different domains of cognition like attention, orientation, memory, language, visuoconstructional capacities, and lastly, executive functions. MoCA is a thirty point test with a score of 25 or less considered as abnormal impaired cognition	3 month after discharge
Primary	Assessment of CT brain was done by ASPECTS.	The ASPECTS scoring was calculated for all patients. CT brain images were assessed for proof of localized parenchymal hypo-attenuation, loss of differentiation between gray and white matter, and if there is effacement of sulci. ASPECTS gives reliable methods for evaluation of ischemic stroke by utilizing a ten-point score "M1, M2, M3, M4, M5, M6, I: insula, IC: internal capsule, L: lentiform, and C: caudate" everyone represents one point. A Score of 10 means a normal CT scan. One point is decreased for each affected area on the CT brain. So, a score of 0 indicates widespread ischemia affecting the MCA territory	7 days